Judgment : 1. The petitioner is accused in C.C.No.372 of 1988 on the file of the Judicial First Class Magistrate No.II, Trichy. 2. He is the proprietor of “Rassons Pharma” situate at No.10-A, Collectors Office Road, Trichy-1. He is having a valid manufacturing licence in Form 28-A to manufacture the drug RASIGLOBIN valid upto 31.12.1988 on 28.5.1987, one G.Dakshinamoorthy, then Drugs Inspector, Karur Range has drawn the sample of RASIGLOBIN Batch No.7404 after complying with all formalities. He sent one such sample to the Government Analyst (Drugs), Madras-6, who in turn analysed the sample and gave a report dated 14.10.1987 that the sample did not conform to the label claim with respect to the content of folic acid, thereby indicating that it was not upto the standard quality drug. 3. On 28.10.1987, a show-cause memo with a copy of the report of the Government Analyst was sent to the firm calling for explanation for the contravention of Sec.18(a)(i) punishable under Sec 27 (d) of the Drugs and Cosmetics Act, 1940 (for short ‘1940 Act’) for having manufactured and sold RASIGLOBIN, not of a standard quality. On 16.11.1987, the petitioner gave a reply. Not satisfied with the reply so given, the respondent launched a prosecution against the petitioner for the aforesaid offence, which is now pending in the aforesaid Calendar Case. 4. On receipt of process, the petitioner has come forward with the present action invoking the inherent jurisdiction of this court to quash the Criminal Proceedings initiated against him. 5. Learned counsel appearing for the petitioner would urge the following points: “(1) Non-performing of protocols of test with regard to the sample is fatal to the case of the prosecution; (2) There is inordinate delay in the launching of the prosecution, the consequence of which was that the petitioner was deprived of the very valuable right inhered in him under Sec.25(4) of the 1940 Act to have the sample tested by the Central Drugs Laboratory, which shall be conclusive evidence of the facts stated therein, inasmuch as the components of the sample of RASIGLOBIN taken from the petitioner could have been deteriorated and not fit for analysis or test.” 6. Learned Government advocate would however repel such submissions. 7.
Learned Government advocate would however repel such submissions. 7. The gravaman of the accusation as against the petitioner, as disclosed by the report of the Government Analyst serving as the basis for the initiation of launching of prosecution is that the sample of RASIGLOBIN taken from the custody and possession of the petitioner was not answering the label claim as regards the folic acid content. It is not at all the case of the prosecution that the said sample was not answering to the label claim of other components. With regard to the folic acid content, the test that had been performed had been indicated in the report in Column 1 for item 2 folic acid. The method adopted was ‘USP’ Method. If the report does not indicate the test or method for determining folic acid content, then it goes without saying that the contention of learned counsel for the petitioner on the first point has to be accepted, the reason being that it is rather a well-settled proposition of law that non-performance of Protocols of test for determining the contents of the components of a sample is fatal to the case of the prosecution. In the case on hand, as indicated above, the protocols of test, as regards folic acid content, had been conducted and in this view of the matter, the first submission of learned counsel for the petitioner bristles next to nothing. 8. At this juncture, learned counsel for the petitioner intervenes and submits that his main thrust is that since the protocols of test of all the components of the sample had not been conducted by the Government Analyst, the prosecution launched against the petitioner has to be thrown lock, stock and barrel. To this submission, I am unable to affix my seal of approval. As already indicated, it is not at all the case of the prosecution that the other components of the sample, other than folic acid, were of below standard and the consistent case of the prosecution is that folic acid content of the sample alone was of below standard, for which prosecution has been launched. 9.
As already indicated, it is not at all the case of the prosecution that the other components of the sample, other than folic acid, were of below standard and the consistent case of the prosecution is that folic acid content of the sample alone was of below standard, for which prosecution has been launched. 9. While elaborating the second submission, learned counsel for the petitioner resorted to draw my attention to the analogous provisions as found adumbrated in the Prevention of Food Adulteration Act, 1954 (for short ‘1954 Act’) as respects the valuable right given to a person accused of an offence under that enactment for sending one such sample to the Central Food Laboratory. The provisions adumbrated in this regard in the 1954 Act vary widely with the provisions adumbrated in the 1940 Act. A consideration of the various provisions in both these enactments is necessary to highlight this point. 10. A procedure had been prescribed under Sec. 11 of the 1954 Act for taking of sample by the Food Inspector. He has to take three samples, send one sample to the Local Health Authority. The Public Analyst, in turn, shall deliver a report to the Local Health Authority of the result of the analysis of any article of food submitted to him for analysis. The Local Health Authority, under Sec. 13 of the 1954 Act, shall after the institution of prosecution against the person from whom the sample of the article of food was taken, forward a copy of the report of the analysis to such person or persons, as the case may be, informing such person or persons that if it is so desired, either or both of them may make an application to the Court within a period of ten days from the date of receipt of the copy of the report to get the sample of the article of food kept by the Local Health Authority analysed by the Central Food Laboratory. When an application is made to the Court, the Court shall require the Local Health Authority to forward the part or parts of the sample kept by the said Authority and upon such requisition being made, the said Authority shall forward the part or parts of the sample to the Court within a period of five days from the date of receipt of such requisition.
The Court in turn shall send such samples to the Director of the Central Food Laboratory for analysis, who shall thereupon send a certificate to the Court within one month from the date of receipt of the part of the sample specifying the result of the analysis. 11. It can be seen from the above provisions that no time limit had been prescribed for launching of prosecution. But, however, time limits had been prescribed as regards the furnishing of the copy of the report of the Public Analyst, Sending of sample by the Local Health Authority to the court on requisition having been made therefor and the submission of the report of the Central Food Laboratory to Court. 12. On other signal provision, as available in this Act, as contra distinguished to the provisions of the 1940 Act, about which I will deal a little later, is that the requisition by the person from whom sample is taken, can come to the court after the launching of prosecution. 13. Sec.23 of the 1940 Act prescribes a procedure for taking of samples by the Inspector of Drugs. This section prescribes taking of three samples, where such sample is taken from the premises wherein drug or cosmetic is manufactured and in other cases, four samples are required to be taken, of course, after observing the requisite formalities as had been indicated therein, which is not relevant for our purpose. The procedure peculiar here is that one such sample taken should be given to the person from whom sample is taken and there is no such provision in the 1954 Act for giving of one such sample to the person from whom sample is taken. The Drugs Inspector is required to send one such sample to the Government Analyst for test or analysis. He is also required to send one sample to the Court, before which proceedings, if any, are instituted in respect of the drug or cosmetic. 14. Sec.25 of the 1940 Act deals with the report of the Government Analyst. The Government Analyst, to whom a sample of any drug or cosmetic had been submitted for test or analysis under Sec.23, shall deliver to the Inspector submitting it a signed report in triplicate in the prescribed form.
14. Sec.25 of the 1940 Act deals with the report of the Government Analyst. The Government Analyst, to whom a sample of any drug or cosmetic had been submitted for test or analysis under Sec.23, shall deliver to the Inspector submitting it a signed report in triplicate in the prescribed form. The Inspector, on receipt thereof, shall deliver one copy of the report to the person from whom the sample was taken and shall retain the third copy for use in any prosecution in respect of the samples. Sub-clause (3) of Sec.25 prescribes that any document purporting to be a report signed by a Government Analyst shall be evidence of facts stated therein and such evidence shall be conclusive unless the person from whom the sample was taken, has within twenty-eight days of the receipt of a copy of the report, notified in writing to the Inspector or the court before which any proceeding in respect of the sample are pending, that he intends to adduce evidence in controversion of the report. Sub-clause (4) states that unless the sample has already been tested or analysed in the Central Drugs Laboratory, where a person has, under Sub-sec.(3), notified his intention of adducing evidence in controversion of the Government Analysts Report, the court may of its own motion or in its discretion at the request either of the complainant or the accused, cause the sample of the drug or cosmetic produced before the Magistrate under Sub-sec. (4) of Sec.23 to be sent for test or analysis to the said Laboratory, which shall make a test or analysis and report in writing signed by, or under the authority of, the Director of the Central Drugs Laboratory the result thereof, and such report shall be conclusive evidence of the facts stated therein. 15. It is rather crystal clear that the report of the Government Analyst shall become conclusive evidence of the facts stated therein, if the person from whom the sample is taken did not notify his intention in clear-cut terms of challenging the report of the Government Analyst, in the sense of intending to adduce evidence in controversion of the report. To put it otherwise, once there is a challenge to the report, the report shall not become conclusive.
To put it otherwise, once there is a challenge to the report, the report shall not become conclusive. The net result is that in the absence of any challenge, the report of the Government Analyst can straightaway be marked as conclusive evidence of the facts stated therein and if there is challenge it cannot be done so, and the facts stated therein have to be proved in the manner allowed by law. An option is given to the Drugs Inspector as well as the person from whom the sample is taken to cause a sample to be sent to the Central Drugs Laboratory for Analysis and such report shall be conclusive evidence of the facts stated therein. It is not necessary either for the Drugs Inspector or the person from whom the sample is taken to wait for the launching of the prosecution for causing a sample to be sent to the Central Drugs Laboratory for the purpose of analysis. This is manifestly clear from the phraseology used in the opening part of Sub-clause (4), namely “Unless the sample has already been tested or analysed in the Central Drugs Laboratory”. As already indicated this sort of a provision is not available in the 1954 Act. 16. In the case on hand, the petitioner, though received the report of Government Analyst enclosed along with the show cause memo issued by the Drugs Inspector on 28.10.1987, did not opt to notify his intention within 28 days from the date of receipt of the Government Analysts report. This will be clear from the sequence of events that took place subsequent to 28.10.1987. The petitioner sent a reply to the show cause memo on 16.11.1987. Such portion of the reply as is relevant for our purpose is couched in the following terms: “On consulting our manufacturing associates M/s.Macro Pharm, they have made a check-up analysis of the batch sample by the Madras Research and Analytical Laboratories, Madras-96 on 6.11.1987 and it shows that the Folic Acid and other contents of the batch is maintained as per the label claim. A copy of the Maral Analytical report is submitted herewith for your kind perusal. And, while the Government analytical report shows that the Folic Acid content is reduced by 70% and the iron content by 8% there is no sign of disturbance in the product like sediment or precipitation etc., which is unbelievable.
A copy of the Maral Analytical report is submitted herewith for your kind perusal. And, while the Government analytical report shows that the Folic Acid content is reduced by 70% and the iron content by 8% there is no sign of disturbance in the product like sediment or precipitation etc., which is unbelievable. This can be readily verified from the sample with you. Some error has obviously crept into the Government analytical report which fact is confirmed by the MARAL Report. In view of the above facts, we would submit that we may not be considered as having contravened the Drug Act. Further, we have recently improved the stability and quality of the product by removing the Calcium lactate from the formula as per the endorsement of the State Drug Controller in Ref.No.11909/D1/3/87, dated 17.7.1987. This may also be taken into kind consideration, and we pray that further action in the matter may be kindly dropped.” 17. The portion as extracted above needs no elucidation, and what all had been stated therein is that certain samples of Rasiglobin of the particular batch number had been sent to Madras Research and Analytical Laboratories and on analysis by them, it was found that a particular batch of Rasiglobin was not at all of sub-standard and some error appeared to have been crept into the report of the Public Analyst. They also improved the stability and quality of the product by removing the calcium lactate and consequently prayed for dropping of further action in the matter. There is no specific averment traceable to this reply notifying his intention in unambiguous manner that he is intending to challenge the report of the Government Analyst, in the sense of intending to adduce evidence, in controversion of the report. 18. Again, another show-cause notice was issued on 23.11.1987 to which he would send a reply on 6.1.1988. Here also, he would state by enclosing two reports, one from the Madras Industrial Cooperative Analytical Laboratory and another from M.B. Laboratories Analytical Chemists and R. & D. consultants, Shenoy Nagar, Madras that Rasiglobin Batch from which sample has been taken is not sub-standard and he would not state anything specifically that he was desirous of adducing evidence in controversion of the report of the Government Analyst.
As such it is abudantly clear that the petitioner has not at all challenged the report of the Government Analyst with 28 days from the date of receipt of the report by notifying his intention in a clear-cut fashion that he is desirous of adducing evidence in controversion of the report. The resultant position is that the report of the Government Analyst shall become conclusive of the facts stated therein. The further sordid fact is that he had not at all exercised his option to send the sample given to him for analysis by the Central Drugs Laboratory even before launching of prosecution. The right which was inhering in him was not at all exercised. It is not as if, as already indicated, he was not having any right to send his sample for analysis by the Central Drugs Laboratory, unless and until prosecution has been launched against him. So the fact that the prosecution in this case had been launched after a delay of eight months admittedly is of no consequence. In such a situation, the petitioner cannot take advantage of his own wrong and no prejudice can be said to have been caused to him by the delay caused in launching the prosecution. In this view of the matter, catena of decisions relied upon by learned counsel for the petitioner of various High Courts and the Supreme Court bearing upon the provisions of 1954 Act need not at all be referred to and a discussion embarked upon. 19. The decision cited under the 1940 Act relates to the decision in M/s. Vilco Laboratories v. The State of Gujarat M/s. Vilco Laboratories v. The State of Gujarat 1975 Crl.L.J. 965 The gravaman of accusation in that case was that Vitamin B Complex tablets supplied by accused were not of standard quality due to short of percentage of Vitamin B1 contents. The report of the Government Analyst had been received by him on 6.4.1968 and he had replied 6y letter dated 2.5.1968 that he did not agree with the report and would adduce evidence in defence. The prosecution thereafter was launched in 1972 after a delay of four years.
The report of the Government Analyst had been received by him on 6.4.1968 and he had replied 6y letter dated 2.5.1968 that he did not agree with the report and would adduce evidence in defence. The prosecution thereafter was launched in 1972 after a delay of four years. In such a situation, it was held that as the accused had complied with the provisions of Sec.25(3) of the 1940 Act, the report of the Government Analyst would not be considered as conclusive under Sec.25(3) and the accused had a right under Sec.25 (4) to send the sample for analysis and test to the Central Drugs Laboratory. But in view of the gross delay of four years in launching the prosecution, during which period Vitamin B1 contents of the sample must have deteriorated to a considerable extent, the accused could not avail of his right under Sec.25(4). Merely on the basis of the report of the Government Analyst, it could not be said that Vitamin B complex tablets were not of standard quality and therefore the finding of the Magistrate on that basis could not be sustained. The aforesaid decision is not at all applicable to the facts of the present case. In the decision, the accused had clearly indicated and notified his intention of challenging the report of the Government Analyst by adducing evidence in defence in controversion of the report. In the case on hand, as already indicated, he has not done so. There are other distinguishing features, as I have already indicated. As such, this decision is of no use and help in advancing the case of the petitioner to any extent whatever. 20. In view of what has been stated above, it goes without saying that the petition deserves to be dismissed and is hereby dismissed.